Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Pharmaceutical Solutions

All Drugs and Chemicals

Geptanolimab Injection,3mg/kg once per 2 weeks

GB226 is administrated at the dose of 3mg/kg, once per 2 weeks (±3 days), and distributed in 100ml of 0.9% sodium chloride solution. The concentration of GB226 shall be strictly controlled at 1mg/ml\~10mg/ml, the duration is 60 min (±10 min) for the first infusion of the drug, and can be reduced to 30 min (±10 min) for the subsequent infusion of the drug if there is infusion related adverse reaction.

GB226

Shawn Yu, master

Lingying Wu

Wu Lingying, Medical PhD

Lingying Wu, Doctor

This study is a multi-center, prospective, open-label, single-arm phase II clinical study to evaluate the efficacy, safety and immunogenicity of GB226 in treatment of recurrent or metastatic cervical cancer patients with PD-L1 positive who failed in platinum-based chemotherapy.

A Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive

Phase II Clinical Study to Evaluate the Efficacy and Safety of GB226 in Treatment of Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive Who Failed in Platinum-based Chemotherapy

To evaluate the efficacy of GB226 as defined by objective response rate, in patients with recurrent or metastatic cervical cancer.

To evaluate the efficacy of GB226 as defined by overall response rate, in patients with recurrent or metastatic cervical cancer.

To evaluate the efficacy of GB226 as defined by time to response in patients with recurrent or metastatic cervical cancer.

To evaluate the duration of response (DOR) of GB242 in patients with recurrent or metastatic cervical cancer.

To evaluate the efficacy of GB226 as defined by progression-free survival, in patients with recurrent or metastatic cervical cancer.

To evaluate the duration from the first administration to death because of any reason in patients with recurrent or metastatic cervical cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive	NCT03808857	Cervical Cancer	GB226	18 Years -	Genor Biopharma Co., Ltd.
A Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive	NCT03808857	Cervical Cancer	GB226	18 Years -	Genor Biopharma Co., Ltd.

Spots Global Cancer Trial Database for recurrent metastatic cervical cancer